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Understanding Regulatory Intermediaries: Perspectives on Third-Party Assurances for Digital Services in Three European Regimes

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  • Medzini, Rotem

Abstract

The ‘assurance problem’ has traditionally centred around verifying that ‘tangible’ products and services comply with legal or regulatory standards through state-led, self-regulatory, or third-party assurances. Its modern accounts focus on proving the trustworthiness of digital services, especially AI-powered ones. This paper applies the regulatory intermediation framework to assess whether third-party assurances, especially those provided by the European New Approach to Technical Harmonisation and Standards, effectively provide assurances, including digital assurances, compared to centralised, state-led authorities. It addresses three key questions: (1) Who are the regulatory intermediaries providing assurance for digital services under the New Approach? (2) How does reliance on these intermediaries differ across three regimes, specifically, the Medical Device Regulation, certifications under the General Data Protection Regulation, and the regulation of high-risk AI under the AI Act? (3) How do these intermediaries perceive the strengths and weaknesses of relying on third-party assurance under the New Approach in providing effective assurances when compared to centralised state-led approaches? This paper utilises document analysis, expert interviews, and stakeholder workshops to identify four key intermediary groups involved in standard setting and conformity assessment, and maps how the three regimes assign responsibilities to them to provide assurances to varying degrees. The paper then demonstrates how intermediaries perceive the strengths and weaknesses of these third-party assurances compared to centralised state-led assurances. It argues that their familiarity and knowledge regarding procedures, interactions, organisational structures, and routines related to their responsibilities can lead to more effective assurances, especially digital ones, with them acting as protectors of fundamental rights, health, and safety.

Suggested Citation

  • Medzini, Rotem, 2025. "Understanding Regulatory Intermediaries: Perspectives on Third-Party Assurances for Digital Services in Three European Regimes," SocArXiv dmsk2_v1, Center for Open Science.
    • Handle: RePEc:osf:socarx:dmsk2_v1
    DOI: 10.31219/osf.io/dmsk2_v1
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    1. Luc Brès & Sébastien Mena & Marie‐Laure Salles‐Djelic, 2019. "Exploring the formal and informal roles of regulatory intermediaries in transnational multistakeholder regulation," Regulation & Governance, John Wiley & Sons, vol. 13(2), pages 127-140, June.
    2. Jean-Pierre Galland, 2017. "Big Third-Party Certifiers and the Construction of Transnational Regulation," The ANNALS of the American Academy of Political and Social Science, , vol. 670(1), pages 263-279, March.
    3. Jacques Pelkmans, 1987. "The New Approach to Technical Harmonization and Standardization," Journal of Common Market Studies, Wiley Blackwell, vol. 25(3), pages 249-269, March.
    4. Ballor, Grace, 2022. "CE Marking, Business, and European Market Integration," Business History Review, Cambridge University Press, vol. 96(1), pages 77-108, March.
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